LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K091574
    Device Name
    SILK BLACK BRAIDED SURGICAL SUTURES, NYLON MONOFILAMENT BLUE AND BLACK SURGICAL SUTURES
    Manufacturer
    SUPPLIDORES UNIDOS INTERNACIONALES, S.A.
    Date Cleared
    2009-10-09

    (129 days)

    Product Code
    GAT
    Regulation Number
    878.5000
    Why did this record match?
    Applicant Name (Manufacturer) :

    SUPPLIDORES UNIDOS INTERNACIONALES, S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    General soft tissue approximation and/or ligation including use in Cardiovascular, Opthalmic, and Neurological procedures.
    Device Description
    AMERICAN SUTURE™ Non-Absorbable Surgical Sutures with/without Needle are Non-Pyrogenic devices used for safe and reliable soft tissue approximation, wound closure, and ligation. American Sutures are made of Silk, Nylon, Polypropylene, and Polyester materials. Sterile, Single Use, Non Absorbable. With or without Needles attached.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1